MRI-Assisted Guidance for Non-Essential Tissue Sampling

June 21, 2026 updated by: Shanghai East Hospital

MRI-Assisted Guidance for Non-Essential Tissue Sampling (MAGNET): an Investigator-initiated, International, Multicentre, Prospective, Pairedcohort, Diagnostic Utility Study

The study aims to determine if a less painful and less invasive prostate biopsy approach is safe for certain men with a high risk of prostate cancer.

Currently, when a man has a suspicious MRI scan, standard medical guidelines recommend a "combined biopsy." This means the urologist performs a Targeted Biopsy (taking 3-5 tissue samples directly from the suspicious area seen on the MRI) followed immediately by a Systematic Biopsy (taking 12 additional samples blindly from the rest of the prostate). While this combined approach maximizes cancer detection, the 12 extra needles from the systematic biopsy increase the risk of bleeding, pain, and urinary infection.

Researchers believe that for men who already have a very high prostate-specific antigen (PSA) level and a highly suspicious MRI, the targeted biopsy alone might be enough to detect any dangerous cancer. In these high-risk men, the extra 12 systematic needles might offer little to no additional benefit ("diminishing returns").

In this study, 850 men will undergo the standard combined biopsy procedure. However, to test the researchers' theory with extreme precision, the tissue samples from the Targeted Biopsy and the Systematic Biopsy will be placed into completely separate, uniquely barcoded jars (the "One Core, One Jar" spatial mapping protocol). The pathologist will examine each tissue sample independently, without knowing which method was used to collect it.

By comparing the results within each patient, the study will determine exactly how many dangerous cancers were found exclusively by the systematic biopsy. If this number is clinically negligible (less than 5%) in men with high PSA levels, it will prove that the 12 extra needles are unnecessary for this specific group.

The ultimate goal of the trial is to safely "de-escalate" prostate cancer diagnostics-sparing high-risk men from the physical trauma, complications, and costs of unnecessary systematic sampling, while ensuring no dangerous cancers are missed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1235

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Shanghai East hospital ethics committee
  • Phone Number: 86-021-38804518
  • Email: siwei_bao@163.com

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Shanghai East hospital ethics committee
          • Phone Number: 86-021-38804518
          • Email: siwei_bao@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age ≥ 45 years. Serum PSA level ≥ 4.0 ng/ml. High-risk MRI findings: Presence of at least one lesion with a PI-RADS score of 4 (Likely) or 5 (Highly Likely) according to v2.1 guidelines11.

Fitness for transperineal prostate biopsy under local or general anaesthesia. Competency to provide informed consent.

Exclusion Criteria:

History of prior prostate biopsy (to ensure baseline risk homogeneity). Prior treatment for prostate cancer or use of 5-alpha reductase inhibitors (5-ARIs) within 6 months.

Candidates who have explicitly opted for focal therapy prior to biopsy (where systematic mapping remains mandatory).

Contraindications to MRI (e.g., incompatible implants, severe renal impairment).

Active urinary tract infection or acute prostatitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Paired Prostate Biopsy Cohort (TB + SB)
Procedure: Paired Prostate Biopsy Cohort (TB + SB)
All enrolled participants (PSA ≥ 4.0 ng/mL and PI-RADS 4-5 lesions) will undergo a standardized paired biopsy procedure during a single clinical session. Step 1: MRI-Targeted Biopsy (TB) of the index lesion(s). Step 2: A standard 12-core Systematic Biopsy (SB) covering the peripheral and transition zones. To allow for independent and unbiased pathological evaluation, biopsy cores will be strictly handled using a high-fidelity "One Core, One Jar" spatial mapping protocol. The diagnostic utility (incremental detection rate) of the systematic biopsy will be compared within-patient and further analyzed across two pre-specified risk strata (PSA 4-20 ng/mL vs. PSA > 20 ng/mL).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary endpoint is the Incremental Detection Rate (IDR) of clinically significant prostate cancer provided by systematic biopsy
Time Frame: within 2 weeks after biopsy
  1. Absolute Marker Framework: Stratified by serum PSA (> 20 ng/ml vs. 4-20 ng/ml).
  2. Relative Marker Framework: Stratified by PSA Density (PSAD), utilizing a pre-specified threshold (e.g., ≥ 0.15 ng/ml² vs. < 0.15 ng/ml²).

Both frameworks aim to validate a 'stopping rule' for systematic biopsy."
within 2 weeks after biopsy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Treatment Management Change
Time Frame: within 2 weeks after biopsy
The proportion of patients in whom the addition of Systematic Biopsy findings alters the recommended treatment plan compared to the plan based on Targeted Biopsy findings alone
within 2 weeks after biopsy
Pathological Upgrading Rate
Time Frame: Within 2 weeks after biopsy
The proportion of patients in whom Systematic Biopsy detects a higher ISUP Grade Group than that detected by Targeted Biopsy.
Within 2 weeks after biopsy
Diagnostic Accuracy Metrics
Time Frame: within 2 weeks after biopsy
Sensitivity, Specificity, NPV, and PPV of the "Target-Only" strategy, using the "Combined Biopsy" result as the composite reference standard.
within 2 weeks after biopsy
Virtual Safety Analysis
Time Frame: within 2 weeks after biopsy
A modelled analysis estimating the reduction in adverse events (e.g., haematuria, retention) if Systematic Biopsy had been omitted in the Experimental Stratum. This is calculated based on the "Number of Cores Saved" multiplied by per-core complication risk coefficients derived from trial safety data.
within 2 weeks after biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai East Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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